Skip to main content
OpenTrials
Completed

NCT Number: NCT02454972

Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Jules Bordet, Brussels, Belgium

Loading trial locations.

About this study

Patients with relapsed small cell lung cancer (SCLC), head and neck carcinoma (H&N), neuroendocrine tumors (NETs), biliary tract carcinoma, endometrial carcinoma, BRCA 1/2-associated metastatic breast carcinoma, carcinoma of unknown primary site, germ cell tumors (GCTs), and Ewing's family of tumors (EFTs) will be enrolled in nine different cohorts. Up to 25 evaluable patients are planned to be enrolled in each cohort (50 in the endometrial carcinoma and 100 in the SCLC cohort).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • Voluntary signed informed consent (IC)
  • Pathologically proven diagnosis of any of the following malignancies:
  • Small cell lung cancer (SCLC).
  • Head and neck carcinoma (H&N). Salivary glands tumors are excluded.
  • Neuroendocrine tumors (NETs), grade 2 and grade 3 according to World Health Organization classification.
  • Biliary tract carcinoma.
  • Endometrial carcinoma.
  • BRCA 1/2- associated metastatic breast carcinoma
  • Carcinoma of unknown primary site.
  • Germ cell tumor (GCTs), excluding immature teratoma, or teratoma with malignant transformation.
  • Ewing's family of tumors (EFTs)
  • Prior treatment. Patients must have received:
  • SCLC, endometrial carcinoma: one prior chemotherapy-containing line.
  • H&N, NETs, biliary tract, CUP: one or two prior chemotherapy-containing lines
  • GCTs: no limit of prior therapy
  • EFTs: no more than two prior chemotherapy-containing lines in the metastatic/recurrent setting.
  • BRCA 1/2-associated metastatic breast carcinoma: at least one but no more than three prior chemotherapy-containing lines.
  • Performance status ≤ 2 [Eastern Cooperative Oncology Group (ECOG)]
  • Adequate major organ function
  • At least three weeks since the last chemotherapy
  • Women of childbearing potential must have pregnancy excluded by appropriate testing before study entry

Exclusion criteria

  • Prior treatment with PM01183 or trabectedin
  • Prior or concurrent malignant disease unless in complete remission for more than five years
  • Known central nervous system (CNS) involvement
  • Relevant diseases or clinical situations which may increase the patient's risk
  • Pregnant or breastfeeding women and fertile patients (men and women) who are not using an effective method of contraception

Treatment and study plan

lurbinectedin (PM01183)

Drug

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

    Overall Response Rate was defined as the percentage of patients with a confirmed response, either CR or PR, according to the RECIST v.1.1. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): ≥30% decrease in the sum of the longest diameters of target lesions compared with baseline; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD

  2. Response by Investigator Assessment

    Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

    When response is the primary endpoint, and thus all patients must have measurable disease to enter the trial, all patients included in the study must be accounted for in the report of the results, even if there are major protocol treatment deviations or if they are not evaluable. Each patient will be assigned one of the following: Complete Response: Disappearance of all target lesions; Partial Response: ≥30% decrease in the sum of the longest diameters of target lesions; Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions; diameter recorded or the appearance of one or more new lesions; Stable Disease: Neither PR or PD; Inevaluable for response: specify reasons (for example: early death, malignant disease, toxicity; tumour assessments not repeated/incomplete; other).

    Normally, all eligible patients should be included in the denominator for the calculation of the response rate for phase II trials.

Secondary outcomes

  1. Duration of Response

    Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

    Duration of Response by Investigator's Assessment, defined as the time between the date when the response criteria (PR or CR, whichever one is first reached) are fulfilled to the first date when disease progression (PD), recurrence or death is documented.

  2. Clinical Benefit

    Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6 (21-day cycle)

    Clinical Benefit Rate was defined as Overall Response Rate or Stable Disease lasting over four months (SD ≥ 4 months)

  3. Disease Control Rate

    Time frame: From the start of treatment to the date of progression or the start of a subsequent therapy or end of patient's follow-up, until Cycle 6

    Disease Control Rate was defined as Overall Response Rate or Stable Disease

  4. Progression Free Survival (PFS)

    Time frame: From the date of first infusion to the date of progression disease, death (of any cause), or last tumor evaluation, up to an average of 5 years

    Progression-free Survival (PFS), defined as the period of time from the date of first infusion to the date of PD, death (of any cause), or last tumor evaluation.

    Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest

  5. Progression-free Survival at 4 Months

    Time frame: At 4 months

    Progression-free Survival at 4, defined as the probability of being free from progression and death after the first infusion at 4 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest

  6. Progression-free Survival at 6 Months

    Time frame: At 6 months

    Progression-free Survival at 6, defined as the probability of being free from progression and death after the first infusion at 6 months. Progressive disease: ≥20% increase in the sum of the longest diameter of target lesions compared with the smallest-sum longest

  7. Overall Survival (OS)

    Time frame: From the date of first infusion to the date of death or last contact, up to an average of 5 years

    Overall survival defined as the period of time from the date of first infusion to the date of death or last contact in case of patients lost to follow-up or alive at the clinical cutoff established for the cohort.

  8. Overall Survival at 6 Months

    Time frame: At 6 months

    Overall Survival at 6 months defined as the probability of being alive after the first infusion at 6 months

  9. Overall Survival at 12 Months

    Time frame: At 12 months

    Overall Survival at 12 months defined as the probability of being alive after the first infusion at 12 months

Sponsors and collaborators

Lead sponsor

PharmaMar

Industry

Registry information

Official study title

A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
May 27, 2015
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.